Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim.  The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA).  Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines.  The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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Double Whammy: Fifth Circuit Affirms Dismissal of Suit Against Generic and Brand-Name Drug Manufacturers

Some product liability suits are dead on arrival. At least, that is the position the Fifth Circuit took late last week in affirming the dismissal of a pro se plaintiff’s suit against a collection of generic and brand-name drug manufacturers.

The case in question is Johnson v. Novartis Pharmaceuticals Corporation, et al., and concerns Mr. Johnson’s purported struggles with Peyronie’s Disease (PD), a connective tissue disorder that causes painful, bent erections, after he had ingested generic forms of the prescription drugs Minocin (an antibiotic) and Tegretol (an anticonvulsant).

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Preemption Torpedoes State Law Claims against Generics Makers in Zantac MDL

A judge in the United States District Court for the Southern District of Florida presiding over the In Re: Zantac (Ranitidine) Products Liability Litigation multidistrict litigation, MDL No. 2924, has held that state labeling and design defect claims against the makers, re-packagers, retailers, and distributors of generic forms for the popular heartburn medication Zantac were preempted by federal law.  The court subsequently dismissed these claims against 32 such Zantac generics makers and distributors.

The Zantac MDL was created by the United States Judicial Panel on Multidistrict Litigation on February 6, 2020.  The plaintiffs allege that ranitidine, the active ingredient in Zantac and its generic forms, breaks down into N-nitrosodimethylamine (“NDMA”), which is part of a group of compounds that have been shown to increase the risk of cancer. The plaintiffs allege a variety of product liability and related claims against the makers and distributors of Zantac and its generic forms under federal and state laws.

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California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal Precedent

Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer, holding that “California law recognizes a manufacturer’s duty to warn the [U.S. Food and Drug Administration] of adverse events.” Mize concluded that California’s duty to warn FDA was “parallel” to the requirements of federal law, and therefore not expressly preempted.

Cases like Mize involving medical devices approved for sale through the FDA’s Premarket Approval (PMA) process are generally subject to the U.S. Supreme Court’s decision in Riegel v. Medtronic, 552 U.S. 312 (2008). Riegel held that the federal Medical Device Amendments preempt state tort laws if they are “different from, or in addition to” the requirements imposed by federal law. Riegel bars state tort law claims because PMA devices are subject to specific requirements adopted by FDA through the rigorous PMA approval process. However, Riegel left open the possibility, based on an articulated judicially imposed policy, that a state might “[provide] a damages remedy for claims premised on a violation of FDA regulations” because “the state duties in such a case ‘parallel’ federal law.” 552 U.S. at 329.

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California Court of Appeal Finds Amazon Is Not Shielded from Liability for Defective Product Sold Through Its Website

In a decision that may impact future e-commerce, the California Court of Appeal held in Bolger v. Amazon.com, LLC that under California law, Amazon could be strictly liable for an allegedly defective battery manufactured by a third-party and sold on its website.  The Court further found Amazon was not immune from liability under the Communications Decency Act.  The Court reversed the trial court’s grant of summary judgment in favor of Amazon.

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Preemption of Structure/Function Claims

Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds strong bones,” “St. John’s Wort supports mood,” and “Vitamin E supports the immune system.”

The FDA defines and regulates structure/function claims, and FDA requirements generally preempt state-law requirements that are “not identical.” 21 U.S.C. § 343-1(a)(5). So, does compliance with FDA regulations for structure/function claims shield food and supplement manufacturers from lawsuits claiming their structure/function claims are false and misleading?

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